Foodborne Illness Litigation – ONLINE EXCLUSIVE

Buried in the FDA’s 600-plus page proposed FSMA regulations might be a nugget for defendants to use in rebutting plaintiffs’ arguments. The FDA states “whatever types of preventive controls a facility chooses to apply in its operations, the requirement…is risk-based. Establishing risk-based preventive controls involves consideration of the available scientific data and information to determine appropriate risk-based preventative controls…” Similarly, the FDAs proposed regulations would require a hazard analysis to “[i]nclude an evaluation of the hazards…to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur.” If the FDA acknowledges the test is “appropriate risk-based preventative controls” for “hazards likely to occur,” why then should courts impose strict liability?

Due Care and the FSMA of 2011. Assuming due care principles apply, all entities in the distribution chain will be judged by their compliance (or non-compliance) with the following: Good Agricultural Practices (GAPs), Good Manufacturing Practices (GMPs), and Hazard Analysis and Critical Control Points (HACCP) plan. They will also be judged on whether they are part of the voluntary Global Food Safety Initiative (GFSI) and their compliancy with GSFI guidance documents and Safety Food Quality (SFQ) codes.

The government long ago waded into the arena by issuing GMP “guidance documents.” The FDA issued a guidance document in the 1970s, and revised it in 2004. Plaintiff lawyers can use the document to establish whether an entity’s GMP was “state-of-the-art.” Now, the government has gone further with the enactment of the FSMA. The FSMA contains a long list of required acts and required forms by entities in the food distribution chain. The required documents will be key in any case and will be treated as the minimum standard of care.

Does the Entity Comply with the Required Government Programs? Registered food facilities are required to conduct hazard analyses and develop and implement written preventive control plans. The written plan must contain the following elements: a hazard analysis (which must be re-analyzed every three years), preventive controls (including controls at critical control points), monitoring, verification, correction actions, and record keeping.

These mandated documents will likely end up being part of a plaintiff’s document request and, depending on the entity’s position in the distribution chain, part of a upstream/downstream document request.

It is anticipated any deposition will key upon the definition of term “preventive controls”:

“Those risk-based reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis…and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.”

As the FDA put it, “we propose to establish qualification requirements for a ‘qualified individual’…a ‘qualified individual’ would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system.” The “qualified individual” would certainly be the target of a plaintiff’s deposition notice (and likely to be the corporate designee witness).

And at deposition, the plaintiff could refer to the FDA’s comments to the proposed FSMA regulations:

• “A written food safety plan is essential for the facility to implement the plan consistently, train its employees, and periodically reanalyze and update the plan.”
• “It [the written food safety plan] is also essential to a facility’s food safety team, to auditors, and to inspectors.”
• “Designing a plan requires an individual who is knowledgeable in the concepts of preventive controls, with associated monitoring and corrective actions…Such knowledge requires scientific and technical expertise developed through training, experience, or both.”

Supplier Verification. Minimization and prevention of hazards is the touchstone. Again, the government has waded into the debate. The USDA charted the National Advisory Committee on Microbiological Criteria for Foods (the “Advisory Microbiological Committee”) to provide guidance on the components of HACCP.